Four US vapor-industry organizations have written to the speaker of the House of Representatives, Paul Ryan, and the House minority leader, Nancy Pelosi, urging them to support a bill that would take the sting out of the Food and Drug Administration’s deeming regulations in respect of electronic cigarettes.
The letter writers believe that the FDA Deeming Authority Clarification Act of 2017, which was introduced by Representatives Tom Cole and Sanford Bishop, would lift the ‘industry-ending’ effect of the retroactive predicate date in the FDA’s regulations.
At the same time, it would institute regulations that better fitted the unique nature of vapor products. Without it, only major tobacco companies would have a chance to survive beyond 2018.
Ensuring this ground-breaking technology continued to be available as a healthier alternative for adult US smokers was key in the mission ultimately to eliminate cigarette smoking and smoking-related disease.
The writers said the FDA’s plan to regulate vapor products out of existence was misguided.
‘There is a large and rapidly growing body of scientific evidence that supports the premise that vapor products are the most important tobacco harm reduction opportunity of the last decade,’ they wrote. ‘The most recent study, published in the Annals of Internal Medicine, conducted and authored by researchers from the US Centers for Disease Control and Prevention (CDC), University College London and King’s College, Roswell Park Cancer Institute, found that consuming e-cigarettes exposes vapers to dramatically lower levels of toxins than smoking conventional cigarettes. Moreover, the difference between smokers’ and vapers’ exposure is actually similar to the difference between smokers and non-smokers, as found by the same CDC scientist in a 2012 study. Additionally, the Royal College of Physicians released a comprehensive scientific review that concluded that vapor products are at least 95 percent less harmful than combusted cigarettes. In the UK, Public Health England published a report recommending these products as a harm-reducing alternative for smokers.’
The writers said the proposed bill would allow an entire vapor products industry to remain afloat, saving tens of thousands of US jobs while providing unprecedented regulation of vapor products appropriate for this innovative technology.
‘Unlike the FDA’s regulations issued in 2016, the Cole-Bishop bill addresses the issues of product safety and enhances youth protections,’ the letter said. ‘Additionally, the legislation provides the strictest industry standards while also preserving access to vapor products for the millions of adult Americans who now use them every day instead of smoking.
‘Specifically, the FDA Deeming Authority Clarification Act of 2017 would:
Amend the current law’s highly-problematic retroactive predicate date from February 15, 2007 to the effective date of the final deeming regulations, allowing products that meet all regulatory requirements to remain on the market and keeping thousands of small businesses, and their tens of thousands of employees, afloat.
Protect consumers by preserving access to the diverse vapor marketplace, as opposed to the current law and FDA’s deeming regulations that threaten to force millions of adult consumers back to smoking or into the black market.
Set higher standards for product safety by requiring the FDA to implement rulemaking on product standards for batteries used in the devices within 12 months.
Protect teens by severely restricting marketing and youth access to vapor products.’
The writers said that if the FDA’s deeming regulations were allowed to stand, small- and mid-sized vapor retailers and manufacturers across the US would close their doors, leaving consumers – who were battling every day to quit smoking – without access to these life-changing and possibly lifesaving alternatives to combustible cigarettes.
‘Although it does not purport to solve every issue with the FDA’s deeming regulations, the FDA Deeming Authority Clarification Act of 2017 is a significant first step toward correcting the FDA’s misguided approach to regulation of the vapor industry,’ they wrote.
The writers are, in alphabetical order, Tony Abboud, executive director of Vapor Technology Association; Alex Clark, executive director Consumer Advocates for Smoke-Free Alternatives Association; Gregory Conley, president American Vaping Association; and Pamela Gorman, executive director Smoke Free Alternatives Trade Association.
Source: Tobacco Reporter
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